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Completed

NCT Number: NCT05452317

Assess Burden of Disease Among Kidney Transplant Recipients With Chronic Active Antibody Mediated Rejection

This study investigates the burden of disease among kidney transplant recipients that have developed Chronic Active Antibody Mediated Rejection (caAMR) compared with kidney transplant recipients that have not developed caAMR

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Keck Medical Center of USC, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Chronic Active AMR group:

  • 18 Years and older
  • Recipient of blood group system (ABO) compatible solitary kidney transplant between [1Jan2013] and [1Jan2018]
  • Chronic active AMR diagnosed via kidney biopsy based upon Banff criteria. Patients who additionally have diagnoses such as TCMR, acute tubular necrosis, recurrence of primary kidney disease are also eligible if not the predominant pathology.
  • DSA antibodies within prior 6 months of the biopsy which confirmed chronic active AMR
  • Minimum of 3 years of follow up data following diagnosis of chronic active AMR (unless patient had died)
  • eGFR at time of diagnosis of chronic active AMR of >25ml/min/1.73m2

Non-Chronic active AMR group:

  • Age 18 years or older
  • Recipient of ABO compatible solitary kidney transplant between [1 Jan 2013] and [1Jan2018]
  • No documented diagnosis of chronic active AMR during the data extraction period. Patients with other diagnoses such as TCMR, acute tubular necrosis, recurrence of primary kidney disease are also eligible. Patients may or may not have had biopsies.
  • Minimum of 4 years of follow up data since transplant (unless patient has died)
  • eGFR of >25ml/min/1.73m2 at time of matching

Exclusion criteria

Chronic active AMR group:

  • Recipient of a multi-organ transplant
  • ABO-incompatible transplant
  • Patient lost to follow up within the first 3 years post-diagnosis of chronic active AMR and whose allograft status (graft failure or patient death) is unknown.

Non-Chronic active AMR group:

  • Recipient of a multi-organ transplant
  • ABO-incompatible transplant
  • Patient lost to follow up within the first 4 years of transplant and whose allograft status (graft failure or patient death) is unknown.

Treatment and study plan

Chronic active AMR group

Other

Past kidney transplant. This is a retrospective, non-interventional, observational study. No study treatment will be administered in this study.

Non-Chronic active AMR group

Other

Past kidney transplant. This is a retrospective, non-interventional, observational study. No study treatment will be administered in this study.

Primary outcomes

  1. Death censored graft loss

    Time frame: 5 weeks

    • eGFR<15ml/min/1.73m2 for > 60 days
    • Hemodialysis for > 60 days
    • Nephrectomy
    • Re-transplant
  2. Decline in eGFR value over time

    Time frame: 5 weeks

  3. Number of sessions received of Haemodialysis/Peritoneal Dialysis

    Time frame: 5 weeks

  4. Number of patients receiving Nephrectomy

    Time frame: 5 weeks

  5. Number of patients receiving re-transplantation

    Time frame: 5 weeks

  6. Number of Hospital admissions per year overall

    Time frame: 5 weeks

  7. Duration of hospital stay (including ICU) per year overall and by primary ICD-10 (ICD-9)/OPCS/HRG code

    Time frame: 5 weeks

  8. Number of ICD-10 (ICD-9)/OPCS/HRG codes

    Time frame: 5 weeks

  9. Number of A&E visits per year overall and by ICD-10 (ICD-9)/OPCS/HRG code

    Time frame: 5 weeks

  10. Number of Outpatient visits per year overall and by ICD-10 (ICD-9)/OPCS/HRG code

    Time frame: 5 weeks

  11. Duration and extent of Haemodialysis/Peritoneal dialysis per year

    Time frame: 5 weeks

  12. Number of Treatments administered for chronic active AMR

    Time frame: 5 weeks

  13. Cost of Hospital admissions (including ICU) per year overall and by ICD-10 (ICD-9)/OPCS/HRG

    Time frame: 5 weeks

  14. Cost of A&E visits per year overall and by ICD-10(ICD-9)/OPCS/HRG

    Time frame: 5 weeks

  15. Cost of Outpatient visits per year overall and by ICD-10 (ICD-9)/OPCS/HRG

    Time frame: 5 weeks

  16. Cost of Treatment administered for chronic active AMR per year

    Time frame: 5 weeks

  17. Cost of re-starting Haemodialysis/Peritoneal dialysis per year

    Time frame: 5 weeks

  18. Cost of nephrectomy

    Time frame: 5 weeks

  19. Cost of re-transplantations

    Time frame: 5 weeks

Secondary outcomes

  1. Per year composite of Myocardial Infarction, Coronary revascularization, Stroke, Hospitalisation due to heart failure, and All-cause mortality

    Time frame: 5 months

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Collaborators

  • UBC Late Stage (UK) Ltd.

Registry information

Official study title

A Retrospective, Chart Review Study to Assess Burden of Disease Among Kidney Transplant Recipients With Chronic Active Antibody Mediated Rejection in the UK

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 11, 2022
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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